BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-FUNNEL REPL GAST 20F

    MDR report key: 9182539 · Received October 11, 2019

    Report

    Report Number
    3006260740-2019-03018
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    July 5, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741037153
    PMA / PMN Number
    K063118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ORIGINALLY DETERMINED TO BE A MALFUNCTION REPORTABLE EVENT ON (B)(6)2019 AND REPORTED TO THE FDA THROUGH THE QUARTERLY VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM. BDPI RECEIVED A NOTIFICATION FROM THE FDA ON (B)(6) 2019 STATING THAT THE PROCODE KNT IS INELIGIBLE FOR THE VMSR PROGRAM; THEREFORE, THE MDR DATE OF AWARENESS WAS MODIFIED TO REFLECT THE DATE OF THE FDA NOTIFICATION OF PROCODE INELIGIBILITY. MANUFACTURER REVIEW: A LOT HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION SUMMARY: ONE TRI-FUNNEL 20F WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS UNCONFIRMED FOR LEAK/AIR WITHIN THE INFLATION CONDUIT, AS NO AIR LEAKAGE WAS NOTED WHEN THE BALLOON WAS DEFLATED. BOTH PORTS ON THE FEEDING TUBE WERE NOT PATENT TO INFUSION AND ASPIRATION DUE TO EXCESS RESIDUE IN THE LUMENS. THE BALLOON WAS INFLATED WITH 20CC OF WATER. THE BALLOON WAS MASSAGED AND NO LEAKS WERE NOTED. ALTHOUGH THE COMPLAINT OF AIR WITHIN THE INFLATION LUMEN OF THE FEEDING DEVICE COULD NOT BE CONFIRMED, AND THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMMEDIATELY AFTER THE FEEDING TUBE PLACEMENT, AS THE GASTROSTOMY FEEDING TUBE WAS FILLED WITH STERILIZED WATER AND THEN DRAINED FROM THE BALLOON, THE AIR WAS ALLEGEDLY IDENTIFIED IN THE FEEDING TUBE. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS ORIGINALLY DETERMINED TO BE A MALFUNCTION REPORTABLE EVENT ON 07/05/2019 AND REPORTED TO THE FDA THROUGH THE QUARTERLY VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM. BDPI RECEIVED A NOTIFICATION FROM THE FDA ON 9/16/2019 STATING THAT THE PROCODE KNT IS INELIGIBLE FOR THE VMSR PROGRAM; THEREFORE, THE MDR DATE OF AWARENESS WAS MODIFIED TO REFLECT THE DATE OF THE FDA NOTIFICATION OF PROCODE INELIGIBILITY. THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS HAS NOT BEEN PERFORMED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY AFTER THE FEEDING TUBE PLACEMENT, AS THE GASTROSTOMY FEEDING TUBE WAS FILLED WITH STERILIZED WATER AND THEN DRAINED FROM THE BALLOON, THE AIR WAS ALLEGEDLY IDENTIFIED IN THE FEEDING TUBE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972485 TRI-FUNNEL REPL GAST 20F FEEDING DEVICE KNT BARD ACCESS SYSTEMS 000720 UNKNOWN 00801741037153

    Patients

    Seq Age Sex Outcome Treatment
    1